In our company, GlaxoSmithKline, a world leader in Consumer and Healthcare products, our people remain the key driving force behind our success. We continuously seek to welcome to the GSK family, talented individuals who will enable us build stronger teams and deliver world class services. We offer all round development, empowerment and a high level of motivation to enable our people deliver superior performance.
Job Title: Clinical Research Associate
The Job
Reporting to the Bio clinical Operations Manager and Head of Medical, the role has the responsibility to:
• Liaise with Medical Advisor(s)/Director and Clinical Operation team to identify suitable investigators for clinical trials.
• Assess investigator’s staff and facilities (working areas, lab, temperature controlled storage)
• Apply a high standard of monitoring, source document verification and compliance with SOPs, ICH GCP and study protocol to ensure high quality data which is acceptable for regulatory submissions.
• Coordinate all clinical research activities onsite as the reference person for the sponsor.
• Ensure that all Serious Adverse Events are reviewed & reported in compliance with SOPs, ICH GCP and local regulatory requirements.
• Track & achieve project milestones and timelines
• Assist the Medical Advisor / clinical Operations Manager to draw up a mutually acceptable and accurate financial/study agreement to ensure optimum management of local trial budgets.
• Take an active role in process development and implementation, in sharing best practices, especially in a regional champion’s role.
• Cultivate and maintain strong working relationships and communication with investigators and GSK staff.
• Ensure proper management /storage/ availability of clinical trial supplies, vaccines and biological samples at site.
• Ensure site staff is appropriately trained according to ICH-GCP/ SOP, SOPs and In liaison with the Regional Training Manager.
• Co-ordinate with Investigators and Medical Director/Central GSM the preparation for internal and external Audits.
• Answer questions, propose specific actions and ensure their implementation in his/her activity area.
The Person
The ideal candidate must have a very good Health Sciences Degree from a-reputable University with a minimum of 3 years post NYSC. Post graduate qualification(s) are an added advantage. H/She must possess a minimum of 3 years experience in Clinical Research, preferably in trial monitoring. A scientific or paramedical background, fluency in English and a working knowledge of French will be valuable in this role.
The candidate must possess:
• Strong leadership skills
• Communication / Negotiation Skills
• Flexibility and Initiative
• Planning and Organizing Skills
• Judgment Skills
• IT literacy
Critical success factors include the ability to:
• Effectively communicate
• Plan and Organize
Candidates must be ready to travel as the business requires.
Method of Application
Interested candidates should forward up-to-date resume in word format (*.doc) or (*.docx) to ng.career@gsk.com, indicating the advertised role as the subject matter. Please note that only electronic applications in the prescribed format will be considered.
Application closes 7th September 2010
http://www.getnaijajobs.com
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